# K183073: SMG Anterior Cervical Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Sapphire Medical Group
- Decided: Feb 11, 2019 after 98 days
- Product code: KWQ (Appliance, Fixation, Spinal Intervertebral Body)
- Device class: 2
- Regulation: 21 CFR 888.3060
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K994239 (2000). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143271: CastleLoc-P Anterior Cervical Plate System, L&K BIOMED Co., Ltd. (2015) Summary page 4.
- K143279: LnK Anterior Cervical Plate System, L&K BIOMED Co., Ltd. (2015) Summary page 4.

## Indications for use
The SMG Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine (C2-C7). The System is indicated for use in the immobilization and stabilization of the spine as an adjunct to fusions in patients with: * degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), * spondylolisthesis, * trauma (i.e. fractures or dislocations), * tumors, * deformity (defined as kyphosis, lordosis, or scoliosis), * failed previous fusion (pseudoarthrosis) * spinal stenosis.

Source page: https://510kreport.com/device/K183073
Methodology: https://510kreport.com/methodology